Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)
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ClinicalTrials.gov Identifier: NCT02392351 |
Recruitment Status :
Completed
First Posted : March 19, 2015
Results First Posted : October 4, 2019
Last Update Posted : February 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Device: Renal Denervation (Vessix) Device: Renal Angiography | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | September 7, 2017 |
Actual Study Completion Date : | August 2, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Renal Denervation
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).
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Device: Renal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
Other Names:
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Sham Comparator: Masked Procedure
Percutaneous renal angiography
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Device: Renal Angiography
Percutaneous renal angiography
Other Name: Renal Angiogram |
- OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks [ Time Frame: Through 8 weeks ]Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)
- Number of Hospitalizations Due to Severe Hypotension/Syncope [ Time Frame: Through 6 months ]Number of hospitalizations due to severe hypotension/syncope through 6 months.
- Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it [ Time Frame: 4 weeks ]Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.
- Renal Artery Dissection or Perforation Requiring Intervention [ Time Frame: 4 weeks ]Number of renal artery dissection or perforation requiring intervention through 4 weeks.
- Vascular Complications [ Time Frame: 4 weeks ]Number of vascular complications through 4 weeks.
- Significant New Renal Artery Stenosis [ Time Frame: 6 months ]Number of significant new renal artery stenosis events through 6 months.
- Number of Subjects Utilizing Anti-hypertensive Medications [ Time Frame: 3 months ]Number of subjects utilizing anti-hypertensive medications at 3 months.
- Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months [ Time Frame: 6 Months ]Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline
- Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months [ Time Frame: 6 Months ]Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.
- Number of Subjects Utilizing Anti-hypertensive Medications [ Time Frame: 6 months ]Number of subjects utilizing anti-hypertensive medications at 6 months
- Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure [ Time Frame: 12 Months ]Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months
- Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure [ Time Frame: 12 Months ]Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months
- All-Cause Death [ Time Frame: 24 Months ]Number of all causes of death through 24 months
- Number of Participants With Renal Failure [ Time Frame: 24 Months ]Number of renal failure events through 24 months
- Number of Participants With Hypertensive Crisis [ Time Frame: 24 Months ]Number of hypertensive crisis events through 24 months
- Mean Reduction in Average Office-based Systolic Blood Pressure [ Time Frame: 24 Months ]Mean Reduction in Average office-based systolic blood pressure through 24 months
- Mean Reduction in Average Office-based Diastolic Blood Pressure [ Time Frame: 24 Months ]Mean Reduction in Office-based diastolic blood pressure through 24 months
- Percent of Subjects at Target Blood Pressure [ Time Frame: 24 Months ]Percent of subjects at target blood pressure through 24 months
- Congestive Heart Failure [ Time Frame: 24 Months ]Number of subjects with congestive heart failure through 24 months
- Myocardial Infarction [ Time Frame: 24 Months ]Number of subjects who experience myocardial infarction through 24 months
- Stroke [ Time Frame: 24 Months ]Number of subjects experiencing stroke through 24 months

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥18 and ≤75 years
- OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements
- Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg
- For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
- Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent
Exclusion Criteria:
- Stenosis >30% or renal artery aneurysm in either renal artery
- Fibromuscular dysplasia (FMD)
- Known causes of secondary HTN
- Type 1 diabetes mellitus
- eGFR <40 mL/min/1.73m2
- Known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months
- Severe valvular heart disease
- ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392351
United States, Alabama | |
Cardiology, PC | |
Birmingham, Alabama, United States, 35211 | |
United States, California | |
Cedars - Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Florida | |
Mount Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 | |
United States, Louisiana | |
Cardiovascular Institute of the South | |
Houma, Louisiana, United States, 70360 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Tufts Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Albert Einstein Medical Center | |
Philadelphia, Pennsylvania, United States, 19141 | |
United States, Tennessee | |
Wellmont CVA Heart Institute | |
Kingsport, Tennessee, United States, 37660 | |
United States, Texas | |
Dallas Medical Center | |
Dallas, Texas, United States, 75006 | |
Cardiovascular Research Institute of Dallas | |
Dallas, Texas, United States, 75231 | |
United States, Wisconsin | |
Aspirus Heart and Vascular Institute | |
Wausau, Wisconsin, United States, 54401 |
Principal Investigator: | Martin B Leon, MD | Columbia University | |
Principal Investigator: | Michael Weber, MD | SUNY Downstate College of Medicine |
Documents provided by Boston Scientific Corporation:
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT02392351 |
Other Study ID Numbers: |
S2333 |
First Posted: | March 19, 2015 Key Record Dates |
Results First Posted: | October 4, 2019 |
Last Update Posted: | February 11, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Hypertension Renal Denervation |
Hypertension Vascular Diseases Cardiovascular Diseases |